Peripheral Artery Disease
Conditions
Keywords
drug eluting balloon catheter
Brief summary
The purpose of this study is to determine whether DEB is more effective than common PTA balloon using under in long-term vessel patency and inhibiting restenosis in the infrapopliteal artery.
Detailed description
PTA is an established alternative to open surgical bypass for the treatment of infrainginual disease of critical limb ischemia. DEBs are designed to promote arterial patency by reducing neointimal proliferation.
Interventions
PROCEDUREDEB catheter
DEB catheter (trade name: Litos/Tulip)
PROCEDUREcommon PTA balloon catheter
common PTA balloon catheter
Sponsors
Acotec Scientific Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 85 years * Patients with peripheral artery disease (PAD), with Rutherford classification between 4 and 6 * an occlusion or a minimum grade of stenosis Primary over 70% in the below popliteal artery * The expected survival time is more than 1 year * signed Patient informed consent form
Exclusion criteria
* Serum creatinine clearance rate less than 30ml/min in patients * patients with acute thrombosis requiring lysis or thrombectomy * patient with a lysis or an lower limb intervention as a therapy within the last 6 weeks * patient requiring intervention in both lower limbs at the same time * In-stent restenosis in the blow-knee popliteal artery * target lesion can't be cross by the guide wire * the stenosis rate of proximal outflow more than 30% with or without intervention * the length of the stenosis or occlusion in proximal outflow(including the Iliac artery, the superficial femoral artery, the Popliteal artery) more than 150mm before intervention * stenosis or occlusion of distal outflow for below-the-ankle artery. * expected major amputations at the index limb before intervention * known hypersensitivity to aspirin, heparin, clopidogrel,paclitaxel, contrast medium, etc. * patients participating in another clinical trials with interfere with this trial in the same time * pregnancy and lactating woman * untreatable bleeding diatheses
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Patency [Time Frame: 6 months] | 6 months | Freedom from target vessel occlusion and clinically driven target lesion reintervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| device success rate | during the operation(after using the DEB catheter) | DEB catheter can reach the target lesions, expand as expected(not broken), and withdraw successfully. |
| technical success rates | during the operation(after using the DEB catheter) | The blood supply of the target lesion recovered after treatment, and residual stenosis less than 50% |
| operation success rate | during the operation(after using the DEB catheter) | both device succeed and technical succeed, and without clinical complication |
| if occured clinically driven TLR( target lesion revascularization) | 6 months, 12 months,18 months, 24 months | Clinically driven TLR is defined as revascularization performed on a patient who returns with clinical symptoms such as: resting pain occur again, ulcer deterioration, new foot ulcers |
| target lesion late lumen loss 6 months | 6 months | measure difference of the MLD(minimal lumen diameter) at 0 time and 6 months |
| Ulcer healing rate | 6 months, 12 months | Healed or not, if not, improving,stagnant, worsening |
| Ulcer healing time | 6 months, 12 months, 18 months, 24 months | Healed or not |
| Change from baseline ankle brachial index(ABI) at 6 months | 6 months | measure ankle brachial index \>1.3 Vascular wall calcification is severe 0.9\ 1.1 Normal range 0.5\ 0.8 Mild and moderate ischemia of lower limb arteries \<0.5 severe ischemia |
| change from baseline Rutherford stage at 6 months | 6 months, 12 months,18 months, 24 months | based the following definition of Rutherford stage, evaluate the stage of patient. Then compare the stage of patient just after procedure and 6 months after treatment Stage clinical symptom 0 asymptomatic 1. mild claudication 2. moderate claudication 3. severe claudication 4. ischemic rest pain 5. minor tissue loss 6. ulceration or gangrene |
| limb salvage in surviving subjects | 30 days, 6 months, 12 months,18 months, 24 months | No Amputation of target limb |
Countries
China
Outcome results
None listed